In 1964, Hagan of the Division of Toxicological Evaluation (DTE) branch of the FDA reviewed the animal toxicity data for Pantopaque that had been submitted with NDA 5-319 (the original NDA for Pantopaque).
He expressed major concerns about the pyrogenicity of the product and suggested a repeat dose after a ten-day interval to investigate further.
This was not apparently ever carried out.
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